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U.S. Department of Health and Human Services

Safety

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Ablavar (gadofosveset trisodium) injection

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) –

August 2013

Summary View

 

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions
  • Have trained personnel and emergency resuscitative equipment available prior to and during Ablavar administration. If such a reaction occurs stop Ablavar and immediately begin appropriate therapy.

 

December 2010

Summary View

 

BOXED WARNING

  • Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (e.g. age > 60 years, hypertension or diabetes), estimate the glomerular filtration rate
(GFR) through laboratory testing.
  • For patients at highest risk for NSF, do not exceed the recommended Ablavar dose and allow a sufficient period of time for elimination of the drug from the body prior to re-administration.

WARNINGS AND PRECAUTIONS

Nephrogenic Systemic Fibrosis (NSF) (section revised)
  • Gadolinium-based contrast agents (GBCAs) increase the risk for nephrogenic systemic fibrosis (NSF) among patients with impaired elimination of the drugs. Avoid use of GBCAs among these patients unless the diagnostic information is essential and not available with non-contrast enhanced MRI or other modalities. The GBCA-associated NSF risk appears highest for patients with chronic, severe kidney disease (GFR < 30 mL/min/1.73m2) as well as patients with acute kidney injury. The risk appears...
  • Screen patients for acute kidney injury and other conditions that may reduce renal function. Features of acute kidney injury consist of rapid (over hours to days) and usually reversible decrease in kidney function, commonly in the setting of surgery, severe infection, injury or drug-induced kidney toxicity…
  • Among the factors that may increase the risk for NSF are repeated or higher than recommended doses of a GBCA and the degree of renal impairment at the time of exposure. Record the specific GBCA and the dose administered to a patient. For patients at highest risk for NSF, do not exceed the recommended ABLAVAR dose and allow a sufficient period of time for elimination of the drug prior to…

PATIENT COUNSELING INFORMATION

  • GBCAs increase the risk for NSF among patients with impaired elimination of the drugs. To counsel patients at risk for NSF:
  • Describe the clinical manifestations of NSF
  • Describe procedures to screen for the detection of renal impairment
  • Instruct the patients to contact their physician if they develop signs or symptoms of NSF following Ablavar administration, such as burning, itching, swelling, scaling, hardening and tightening of the skin; red or dark patches on the skin; stiffness in joints with trouble moving, bending or straightening the arms, hands, legs or feet; pain in the hip bones or ribs; or muscle weakness.